The QA/QC Philosophy in Pharmaceutical industry

the differences between the quality assurance and the quality control and the different philosophies behind it. And We'll talk about the importance of establishing a quality assurance philosophy throughout the whole organization. We will also talk about the importance of performing monthly trend analysis and how it would benefit your establishment in the long run. I find a lot of companies think about the department and the role of the department, not the function or the culture, as quality control and quality assurance. Now the big difference being the quality control department can perform some Quality Assurance Functions so the quality control aspects can be difficult for people to grasp so I use a slightly simplified model I put call the quality control the activities that happen at the end of the process so the testing you do for final release and Quality Assurance the actions that you do before the process.So for example, if you want to add a install a new machine you do your change control that's quality assurance if you're doing your validation you're still on Quality Assurance quality control doesn't actually getinvolved until you finish your validation and you actually manufacture new product so the quality control is a testing then that you carry out at the end of the manufacturing process. Yeah so that sounds right so usually when I talk about quality control I speak about their release analysis, the raw material testing and less of documentation oversight. that's right so in quality control you you're doing the checks that use make sure that it's actually as you expected it to be at the end and a quality assurance culture you're more looking at how the control plan can be used throughout the process to ensure at the end of the manufacturing process you're going to have a product that you know before you even get to test it is going to meet the specification. So a good example is aseptic. manufacturing so with their septic manufacturing you rely on the controls you have in place more than you rely on on the finished tests because you can do a sterility test at the end of the manufacturing process but you're only looking at a small number of samples. Well relative to the size of the batch. So if you want to be confident that your products actually safe to be administered to a patient, then you want to make sure that all the controls in place up to that point have been acceptable, that they've been done properly, that they've been documented properly and that the process that you've used is as you prescribed it in the control plan. Yeah I see that exactly like that. So would you say that the problem that you're talking about is the mix-up, the misunderstanding is the problem of rather small companies rather than big companies? Unfortunately, I see the similar problems in large companies. So for example when you come to look at trend analysis. Now trend analysis is preempting a problem and unfortunatelyI find even larger companies look at trend analysis and say oh well it's inspec so it's okay. But they fail to review the fact that they've had the last four or five test results over whether it's weeks or months with an increase in value and they're just about to approach the action limit. So would you say that the Quality Assurance department doesn't do enough there? Maybe they don't have enough oversight or maybe those companies don't even have a separate Quality Assurance unit? They have the unit they just don't understand the differentiation so they just look at- yes it means the final specand release it based on that or accept to the results based on that unfortunately it's often the Quality Assurance Department that's doing the review of the trend and just accepting it based on it meets the finished product spec. And I find that I go out and I hold it and rather than just auditing and identifying issues with a company I'm out there training them as well at the same time. Because for me if they understand. If they're my supplier then it's better for me if they understand how to make sure the products are going to be right because otherwise there's a risk that I'm going to get out of stock just as much as they are. Because if I'm relying on their products coming to me I want them to be confident in their manufacturing process so that they're not going to get to the end and not be able to release it to me. Yeah so as I see it still seems to be like some oversight from the quality assurance that their operations are not set good enough for maybe they don't look at the trends analysis they maybe look more at out of spec situations but they don't look enough at out of trend situations. Is this the case? That was just an example to be honest. If you were educating the company you wouldn't restrict it to the Quality Assurance Team you need to be confident that your own validation team are working in the appropriate way of setting the right control measures making sure that they're doing the right tests you also need to be confident that your engineering team are doing the preventative maintenance on time and they understand why if they don't that they have to notify somebody. You need to look at the purchasing team to make sure that they're not looking to reduce costs and impact the product. An example I can give is the purchasing teams for a company I used to work for they were looking at methyl cellulose, asa filler in the tablets and they're just the global team were looking at reducing the cost of it because they purchased a lot across the whole of the company around the world. Now they said basically oh it's the same product it's got the same finished product spec  just put it into the product and we'll get this cost serving. But I was in charge of the change control procedure at the time fortunately and I insisted that the purchasing manager did a test and tried to manufacture it and what they found was that the tablets actually fell apart within three but usually you'll find that the actual manufacturing process itself the people running it will know if they tweak this particular setting that it goes out of range or if they follow the exact process that they've been trained in they have to do a slight amendment to get it to go out and pass and it's sometimes hard to get them to admit that they do something slightly different because of course they're then not doing it according to the way that the main trend and the way it's documented so you have to go through from the start to the finish and do trials slightly outside the standard range now you're looking at between five and ten percent depending on the robustness of the process so you want to look at the temperature slightly higher and slightly lower than what you would normally manufacturer you want to look at the humidity slightly higher slightly lower you want to look at your actual materials right at the top of the spec right at the bottom of the spec and if you find that at the top of the spec you have a problem with your finished product or you have your problem with your manufacturing process then you can increase the robustness of your process by insisting that you get aspect that works better and by looking at all the different parameters especially especially identifying the critical parameters within your process and putin controls in place within the process so you might want to do CPK control charts and by looking at the control charts and seeing how how many times you need to do your judgments when you need to do just months what impact it has youthen have a better understanding of how your process works and what impacts your finished product now it does seem like a lot of work and to be honest if you've already got a product that you've manufacturing and you've been doing it for a number of years it's better to actually restrict it to the data that you've already got and you we have already got especially the failures so if you look at the failure modes for your product use your deviations on your non conformance errs and your complaints you can then identify the areas first to target so for example if you if you're doing soft gel capsules look first at temperature and humidity because the soft gel is impacted by temperature and humidity if you're looking at hard gel capsules then look at you seen integrity and your humidity because they become brittle if their humidity goes out if you're looking at tablets look at you actually look at your production process for the tablets itself that the compression machine sorry I can't think of the compression if you you look at the compression machine and whether you've got a Dee duster in place how your actual machine is compressing where the what controls you've got because you can get now machines that have got the compression strength included so they actually measures every single tablet as it's manufactured but then of course you need to look back at your florets make sure you've got your materials.